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Amogha Pharma Consultancy was started by Gurudatta
GG in Feb 2006 ,having a vast experience of 22 years in various
areas of Pharma Industry.
He has worked in Quality Control department, Quality assurance department,
Analytical Development, Regulatory Affairs and formulation Development.
He has been trained by WHO Geneva for Quality Management systems.
He has faced and successfully cleared many international regulatory
audits like MCC South Africa, MHRA UK, TGA Australia, WHO Geneva,
and USFDA. Apart from this he has faced many international clients
audits also.
He was working with Strides Arcolab Limited, Bangalore and IPCA
Laboratories (Athal Plant) as Head QA.
Presently Amogha Pharma consultancy has many clients in soft gelatin
capsules manufacturing, Tablets and liquid orals manufacturing plants,
sterile products manufacturing unit ( SVP) and API manufacturing
facility.
There are many technical experts who are supporting externally to
Amogha Pharma consultancy who have got more than 30 years experience.
Amogha Pharma Consultancy was started with an aim
of providing Total Pharma Business solutions to organizations.
We give consultancy in various areas of Pharmaceutical
business as mentioned below:
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Quality
Management system design and implementation; monitoring of
quality system and quality of the products manufactured at
plant level. |
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Analytical method
development and method validation |
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Formulation development
for Para 3 filings ( Generic formulations) |
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Training : GMP,
GLP, GCP and evaluation of training |
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Auditing: Third
party auditing of API, Pharmaceutical formulations plants,
Clinical research Organisations facilities. |
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Project Management:
From Conceptualization, design and construction to Qualification
and validation of Equipment and systems |
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Contract Manufacturing
of Pharmaceutical formulations |
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Dossier management:
Dossier preparation and submission |
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Contract manufacturing
of Cosmetics for various countries |
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Clinical research:
Phase -2 , Phase 3 and Phase 4 trials and Bioequivalence studies |
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Placement services
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